Work

Preliminary laboratory analytical comparison of quantitative at-home urinary hormone monitoring systems using artificial urine

Year: 2026

Type: article

Abstract: Background: Quantitative at-home urinary hormone monitoring systems are increasingly used for reproductive health tracking, but their analytical behaviour requires systematic characterization. This preliminary laboratory comparison aimed to provide an analytical framework to compare multiple commercially available at-home urine hormone monitoring devices across key performance metrics under controlled artificial urine conditions. Methods: Laboratory experiments were informed by Clinical and Laboratory Standards Institute's (CLSI) validation principles. Four urine hormone monitoring devices were evaluated using a pre-registered analytical framework for luteinizing hormone (LH), follicle-stimulating hormone (FSH), estrone-3-glucuronide (E3G), and pregnanediol glucuronide (PDG). Metrics included coefficients of variation (CV, for precision), relative deviation (RD, for accuracy), linearity, limit of blank (LoB), limit of detection (LoD) for each device, using artificial urine samples with standard hormone concentrations. Cross-reactivity was tested with other hormones including human chorionic gonadotropin (hCG), cortisol, thyroid stimulating hormone (TSH) and progesterone subtypes. Device-specific evaluations, including the impact of ambient light and various camera systems, were also conducted for relevant devices. Results: There were device- and analyte-specific differences in precision, accuracy, linearity and detection limits. Precision and accuracy ranged from CV/RD values near the 15% acceptability threshold to levels exceeding 50% at some concentrations. External lighting conditions affected camera-based strips at low hormone concentrations. False positive results for LH can occur in the presence of 100 mIU/mL hCG, which could lead to misinterpretation in the context of pregnancy. One device that measures the LH-beta subunit avoided this cross-reactivity. Conclusions: A preliminary analytical framework was applied to evaluate the performance of quantitative urinary hormone devices for at-home use. This framework can be used in future research and development of menstrual health monitoring technologies. Longitudinal clinical studies using human urine samples and appropriate ovulation reference standards are required before conclusions can be drawn regarding ovulation detection, fertile-window estimation or menstrual-phase classification.

Source: Frontiers in Endocrinology

DOI: 10.3389/fendo.2026.1947016

Authors: Thomas P. Bouchard, Paul J. Yong, Patricia K. Doyle-Baker

Institutions: University of British Columbia, University of Calgary

Language: English

Topic: Clinical Laboratory Practices and Quality Control

Subfield: Medical Laboratory Technology

Field: Health Professions

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,801